Graeme Laurie

The social licence for research: why care.data ran into trouble

In this article we draw on the concept of a social licence to explain public concern at the introduction of care.data, a recent English initiative designed to extract data from primary care medical records for commissioning and other purposes, including research. The concept of a social licence describes how the expectations of society regarding some activities may go beyond compliance with the requirements of formal regulation; those who do not fulfil the conditions for the social licence (even if formally compliant) may experience ongoing challenge and contestation. Previous work suggests that peoples cooperation with specific research studies depends on their perceptions that their participation is voluntary and is governed by values of reciprocity, non-exploitation and service of the public good. When these conditions are not seen to obtain, threats to the social licence for research may emerge. We propose that care.data failed to adequately secure a social licence because of: (i) defects in the warrants of trust provided for care.data, (ii) the implied rupture in the traditional role, expectations and duties of general practitioners, and (iii) uncertainty about the status of care.data as a public good. The concept of a social licence may be useful in explaining the specifics of care.data, and also in reinforcing the more general lesson for policy-makers that legal authority does not necessarily command social legitimacy.

Reflexive governance in biobanking: on the value of policy led approaches and the need to recognise the limits of law

Although a few jurisdictions around the world have legislated in response to the phenomenon of biobanking, the far more common response has been policy led with funders and other stakeholders initiating multi-level policy initiatives to guide biobanking practice. An example of this is UK Biobank which has developed and operates according to an Ethics and Governance Framework. Such an instrument has no basis in law and yet it has played a crucial role in the set up and ongoing management of the resource. It will continue to do so, as related policies emerge, such as access and intellectual property policies. Numerous biobanking initiatives have similar high-level policy documents that guide decisions and practice. These are often framed as a commitment to participants, researchers and society more broadly and invoke notions such as the public good and the public interest. As such, they serve as a benchmark against which to measure a biobank’s performance. Moreover, policies become an important means by which biobankers are held accountable. This article critically analyses this policy-driven phenomenon asking how effectively policy—often as an alternative to law—serves to police and to promote biobanking. It argues that a policy of reflexive governance—defined and developed herein—can best meet the challenges faced by many biobanks and without the need for recourse to law.

The Stem Cell Research Environment: A Patchwork of Patchworks

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a ‘patchwork of patchworks’. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

Evidence of support for biobanking practices

Lack of dissent in opt-in mechanisms does not necessarily support a move to opt-out

Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together.

This article advances a principled proportionate governance model (PPGM) that overcomes key impediments to using health records for research. Despite increasing initiatives for maximising benefits of data linkage, significant challenges remain, including a culture of caution around data sharing and linkage, failure to make use of flexibilities within the law and failure to incorporate intelligent iterative design. The article identifies key issues for consideration and posits a flexible and accessible governance model that provides a robust and efficient means of paying due regard to both privacy and the public interests in research. We argue that proportionate governance based on clear guiding principles accurately gauges risks associated with data uses and assigns safeguards accordingly. This requires a clear articulation of roles and responsibilities at all levels of decision-making and effective training for researchers and data custodians. Accordingly, the PPGM encourages and supports defensible judgements about data linkage in the public interest.

Towards Principles-Based Approaches to Governance of Health-related Research using Personal Data.

Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles-based approach, contrasting this with traditional rule-based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

Recognizing the Right Not to Know: Conceptual, Professional, and Legal Implications

This article argues for the importance of conceptual clarity in the debate about the so-called right not to know. This is vital both at the theoretical and the practical level. It is suggested that, unlike many formulations and attempts to give effect to this right, what is at stake is not merely an aspect of personal autonomy and therefore cannot and should not be reduced only to a question of individual choice. Rather, it is argued that the core interests that can be protected by the right not to know are better conceived of as privacy interests rather than autonomy interests. This not only helps us to understand what is in play but also informs regulatory, professional, and legal responses to handling information and taking decisions about whether or not to disclose information to persons about themselves. The practical implications of this conceptualization are explored in the context of feedback policies in health-related research.

Acting on incidental findings in research imaging.

Incidental findings of imaging research studies can turn healthy individuals into anxious patients, while putting an extra burden on primary care. J M Wardlaw and colleagues argue that doctors should ensure that the personal, ethical, healthcare, and cost implications of these common findings are managed proportionately, sensitively, and economically

Balancing open source stem cell science with commercialization

To the Editor: Experience has shown that early-stage choices made in setting up regulatory systems in the life sciences can, in unanticipated ways, determine the eventual scope for innovation and the delivery of public benefits from scientific discoveries1,2. An example is stem cell science and regenerative medicine therapies where, although the UK regulatory system has succeeded in facilitating basic stem cell research, downstream development of therapies must navigate an increasingly challenging regulatory system. The United Kingdom took an early lead in establishing regulations for research on human embryonic stem cells (hESCs) in a way that clearly serves the needs of the research community. However, the needs of those who will translate the basic research into therapies are not always aligned with those of basic researchers. In the United Kingdom, this has led to a paradoxical situation in which the regulations that favor basic research are restricting commercial investment. The UK governance system for the use of hESCs in scientific research includes the following: first, the Human Fertilisation and Embryology Authority (HFEA) research license for embryo research; second, the arrangements for curation and distribution of ethically sourced, high-quality stem cell lines via the UK Stem Cell Bank (UKSCB; London, UK); third, the Code of Practice for the Use of Human Stem Cell Lines (http://www. ukstemcellbank.org.uk/codesofpractice/ codeofpracticefortheuseofhumanstemcelllines. cfm); and fourth, the Steering Committee for the UKSCB and for the Use of Stem Cell Lines (the Steering Committee). The HFEA requires, as a condition of granting a research license, that samples from any hESC line generated in the United Kingdom in the course of that research must be deposited in the UKSCB. This requirement has also been adopted by UK research councils as a contractual condition of public funding for embryo stem cell research. The terms by which a hESC sample is deposited at the UKSCB are defined by a Materials Deposition Agreement (MDA), and those wishing to access cells from the UKSCB must enter into a Research Use Licence (RUL). These agreements follow the principles set out in the UKSCB Steering Committee Code of Practice, designed to provide guidance on best practice to those working with stem cell lines, to specify an oversight mechanism for research involving hESC lines, and to provide confidence and reassurance to professionals and the public (http:// www.ukstemcellbank.org. uk/_db/_documents/Code_of_Practice_ for_the_Use_of_Human_Stem_Cell_Lines_ (2010).pdf). For researchers deriving new hESC lines under a HFEA license, these arrangements are almost mandatory because the researchers are obliged to deposit samples with the UKSCB and failure to do so may result in refusal or withdrawal of their license by the HFEA. An important aspect of these arrangements is their underlying ‘open source’ ethos whereby, under the terms of the MDA and the RUL, any cell line deposited at the UKSCB will be made available to researchers for noncommercial and nonclinical use. Depositors or subsequent developers of the cell line will not be able to prevent release of samples from their cell lines to third-party researchers, other than for a limited period and in a limited area of research. This means that no one party can maintain control over a particular hESC line and its derivatives. This UK governance system is intended to minimize the number of embryos used in research and to facilitate research that could lead to successful human therapies. However, it needs to be seen in the context of existing regulations relevant to the further development of human therapies3. In Europe and the United States, a pharmaceutical model has been adopted that requires preclinical and clinical (phase 1, 2 and 3) trials before a cell or tissue therapy can be approved for clinical use by the European Medicines Agency (EMA)4 or the US Food and Drug Administration (FDA)5. The cost of developing a stem cell therapy according to this model is likely to be similar to that for a drug—in the range of £250 (

Involving Publics in Biobank Governance: Moving Beyond Existing Approaches

400) million to £800 (